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ABEM LLSE 2005: Dex in meningitis

This quiz covers essentials of the paper by DeGans, et al, NEJM 2002 347(20):1549-6. Remember, this quiz isn't just about "teaching to the test," it's about the paper itself.

AB
Where and when did this paper appear?NEJM; 111402
What was the steroid dosing regimen?Dexamethasone 10mg IV Q6 hours; given either 15-20 minutes prior to antibiotics; or concurrently with antibiotics.
What was the antibiotic regimen in this trial?Most patients got amoxicillin 2g IV Q 4 hours X 7 – 10 days; this regimen was based on known susceptibility patterns in the Netherlands; and was subject to change depending on Grams staining.
What was the general design of this study?Prospective; randomized; placebo-controlled; double-blind trial
How many patients were enrolled?301; 157 to dexamethasone; 144 to placebo
What is the theoretical benefit of steroids in the setting of bacterial meningitis?Animal studies suggest that bacterial lysis instigated by antibiotics leads to subarachnoid inflammation; neuronal death; bad brain; and other unfortunate stuff.
T or F: all patients in this study received steroids 15 – 20 min prior to antibiotic tx.False. Study protocol was ammended after interim analysis to allow co-admin of steroids and abx—primarily to improve the rate of patient enrollment.
What was the primary outcome measure in this study?Glasgow Outcome Score (not to be confused with the Glasgow Coma Score)
Describe the Glasgow Outcome Score1 – death; 2 – vegetative state; 3 – severe disability; 4 – moderate disability; 5 – mild or no disability.
What did the investigators consider to be a favorable primary outcome?4 or 5 on the Glasgow Outcome score.
What were the secondary outcome measures in this study?Death; focal neurological abnormality (aphasia; CN palsy; monoparesis; hemiparesis; ataxia); hearing loss; GI bleed; fungal infection; herpes zoster; and hyperglycemia.
T or F: This study was manufacturer-supportedTrue: partly funded by a grant from NV Organon
How were study results reported?As relative risk; which of course gives an inflated impression of the actual benefit
The study design of this paper incorporated a “last observation carried forward” methodology. Explain.Patients who left the study after randomization were included in the final analysis; with their last observed characteristics “carried forward.” So a patient with a GOS of 4 who was lost to followup at 3 weeks was still used in the 8 week analysis; utilizing the GOS of 4.
T or F: Patients treated with dexamethasone had statistically higher rates of GI bleeding; herpes; fungal infection and hyperglycemia than patients in the placebo group.False. More patients in the dex group had hyperglycemia (50 vs 37); herpes (6 vs 4) and fungus amongus (8 vs 5); but the differences were not statistically significant.
T or F: anbitiotic treatment was highly standardized in this study.False.
Eight weeks after treatment; the ABSOLUTE risk reduction of an unfavorable outcome in dex-treated patients was 10%. What was the number-needed-to-treat?10.
T or F: Adjuvant treatment with dex had a significant beneficial impact on neurologic sequelae; including hearing lossFalse. The authors argue because these sequelae are most often seen in severe disease; and because dex improves survival; dex may have paradoxically resulted in more sequelae. But they ALSO say that lower mortality did not result in increased rate of sequelae. Take your pick.
T or F: many of the patients in this study had subtle presentations of meningitis.False. This study relied heavily on a population with relatively clear-cut cases of meningitis. Accordingly; there is some concern as to whether the results can be generalized to “all comers” with r/o meningitis; including those pts who aren’t as “sick” at presentation.
T or F: The authors note that there is data that a two-day steroid regimen is as effective as four-day; and recommend use of either regimen.False. The authors recommend a four-day regimen.
T or F: on subgroup analysis; patients with pneumococcal meningitis demonstrated a significant benefit from dex; while those with Neisseria meningitis did not.True.


aka Dr. Dog
Departments of Emergency Medicine and Physiology

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